Eso-Sponge Registry
- Conditions
- Leakage After EsophagectomyLeakage After GastrectomyPerforation of the Esophagus
- Registration Number
- NCT02662777
- Lead Sponsor
- Aesculap AG
- Brief Summary
This international, prospective and multicenter registry was designed to collect clinical evidence for the endoscopic vacuum treatment using Eso-SPONGE® for anastomotic leakage after esophageal resection or iatrogenic or spontaneous esophageal perforation.
- Detailed Description
Anastomotic Leakages or other defects in the upper gastrointestinal tract can have serious consequences for the affected patients. Different parameters, like the size, location, time to diagnosis of the lesion, but also the general condition of the patient, have a significant influence on the clinical outcome of the patient. Often this situation is accompanied by symptoms of sepsis and a significant morbidity rate with corresponding substantial mortality rate. For this reason the treatment of this clinical situation is often a challenge for the clinician.
Besides surgical examination and the endoscopic stent system, good experiences have been obtained with the Endo-SPONGE® therapy for the lower gastrointestinal tract. In the future the endoluminal vacuum therapy for the upper gastrointestinal is available, too, with Eso-SPONGE®.
Eso-SPONGE® represent an innovative therapy concept for the treatment of this problem in the upper gastrointestinal tract, which can contribute significantly to the reduction of morbidity and mortality of the patients.
The overall success rate of endoscopic esophageal vacuum therapy in the literature ranges from 80-100%. Currently only cohort studies including a small number of patients have been performed and published. Therefore an international, prospective and multicenter registry was designed to collect clinical evidence for Eso-SPONGE treatment concept in a large population under daily clinical routine.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 108
- Endoscopic vacuum therapy (EVT) of anastomotic leakage after esophageal resection or spontaneous or iatrogenic perforations
- age > 18 years
- written informed consent
- none
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Healing rate of the esophageal anastomosis leakage or esophageal perforation until day of discharge (approximately 2 weeks) Reduction of the cavity, endoscopic vacuum therapy no longer necessary
- Secondary Outcome Measures
Name Time Method Number of Eso-SPONGE® changes until day of discharge (approximately 2 weeks) Total number of sponges used until day of discharge (approximately 2 weeks) Total number of Eso-SPONGE® units used until day of discharge
Average replacement intervals until day of discharge (approximately 2 weeks) Period of time between exchange of ESO-Sponge®
Duration of endoscopic vacuum therapy until day of discharge (approximately 2 weeks) Number of days during which Eso-SPONGE® was applied
Complication Rate until day of discharge (approximately 2 weeks) Number of Complications during endoscopic vacuum treatment (e.g. death, re-operations, stenosis, pneumonia, peritonitis, mediastinitis)
Trial Locations
- Locations (17)
Siloah St. Trudpert Klinikum
🇩🇪Pforzheim, Baden-Württemberg, Germany
Sankt Katharinen Krankenhaus
🇩🇪Frankfurt, Hessen, Germany
Klinikum Herford
🇩🇪Herford, Hessen, Germany
Asklepios Klinik
🇩🇪Lich, Hessen, Germany
Klinikum Lüneburg, Klinik für Allgemein-, Viszeral- & Thoraxchirurgie
🇩🇪Lüneburg, Niedersachsen, Germany
Klinikum Wilhelmshaven
🇩🇪Wilhelmshaven, Niedersachsen, Germany
Augusta-Kliniken GmbH
🇩🇪Bochum, Nordrhein-Westfalen, Germany
St. Johannes-Hospital Dortmund
🇩🇪Dortmund, Nordrhein-Westfalen, Germany
EVK Herne
🇩🇪Herne, Nordrhein-Westfalen, Germany
Universitätsklinikum Kiel
🇩🇪Kiel, Schleswig-Holstein, Germany
Scroll for more (7 remaining)Siloah St. Trudpert Klinikum🇩🇪Pforzheim, Baden-Württemberg, Germany